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Sponsored studies which were completed/closed at our location within the past five years:

Cornea/External Disease:

Oculoplastics:

Tears and Eyelid Surgery Study
Sponsor: CUSOM/Department of Ophthalmology          COMIRB#: 12-1356
Faculty: Hink (PI)
Changes in Tear Film Osmolarity After Eyelid Surgery.

Meibography before and after lid surgery
Sponsor: CUSOM/Department of Ophthalmology          COMIRB#: 17-1673
Faculty: Hink (PI), Liao, Echalier, Neems

Teprotumumab Treatment in Patients With Active Thyroid Eye Disease
Sponsor: RiverVision   NCT#:
Faculty: Hink (PI), Liao
Placebo-controlled study of an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody administered every 3 weeks by intravenous infusion in patients suffering from active thyroid eye disease.

Retina:

Argus II Retinal Prosthesis for Retinitis Pigmentosa
Sponsor: Second Sigh​t Medical Products                     NCT#:
Faculty: Mandava (PI), Oliver
Argus® II Retinal Prosthesis System Post-Approval Study

Visual Function after Macula-off Retinal Detachment
Sponsor: ONL Therapeutics                                       COMIRB#: 14-1227
Faculty: Mandava (PI)

Clear II: Uveal Melanoma
Sponsor: CUSOM/Department of Ophthalmology         COMIRB#: 18-1410
Faculty: Oliver (PI)

Triamcinolone Acetonide Injectable for the Treatment of Non-infectious Uveitis with Macular Edema (PEACHTREE)
Sponsor: Clearside Biomedical, Inc.                 NCT#: 
Faculty: Palestine (PI), Mathias, Siringo
Evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

Study of Fovista with either Avastin or Eylea compared to Avastin or Eylea Monotherapy (OPH1004)
Sponsor: Ophthotech Corporation                             NCT#:
Faculty: Mandava (PI), Mathias, Olson, Oliver, Siringo
Evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis against a control of Lucentis alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Port delivery system for sustained delivery of ranibizumab for Neovascular Macular Degeneration (LADDER)
Sponsor: Genentech, Hoffmann-La Roche                  NCT#:
Faculty: Oliver (PI), Mandava, Mathias, Olson, Pecen
To evaluate the efficacy, safety and pharmacokinetics of three different formulations of ranibizumab delivered via implant compared with the standard of care.

Suprachoroidal Triamcinolone Acetonide for Non-Infectious Uveitis (AZALEA)
Sponsor: Clearside Biomedical                                  ​ NCT#:
Faculty: Palestine (PI), Pecen, Siringo

Open-label Lampalizumab for Geographic Atrophy (OMASPECT)
Sponsor: Hoffman-La Roche                                      NCT#:
Faculty: Siringo (PI), Mandava, Olson, Mathias, Pecen
Extension study of SPECTRI.

Ranibizamab vs Laser for Retinopathy of Prematurity (RAINBOW)
Sponsor: Novartis Pharmaceuticals                            NCT#:
Faculty: Oliver, Siringo
To determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

Lampalizumab vs Sham for Geographic Atrophy (SPECTRI)
Sponsor: Hoffman-La Roche                                      NCT#:
Faculty: Oliver (PI)​, Olson, Siringo, Mathias
To evaluate the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Study Assessing Double-masked Uveitis Treatment (SAKURA)
Sponsor: Santen Inc.                                             NCT#:
Faculty: Palestine (PI)
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution for the treatment of active, non-infectious uveitis.

Retinal Imaging for Familial Adenomatous Polyposis and Congenital Hypertrophy Sponsor: CUSOM/Department of Ophthalmology         COMIRB#: 14-1227 Faculty: McCourt (PI) Familial Adenomatous Polyposis and Congenital Hypertrophy of the Retinal Pigment Epithelium.

RAINBOW extension study: an extension study to evaluate the long-term efficacy and safety of Ranibizumab compared with laser therapy for the treatment of Infants Born prematurely with retinopathy of prematurity Sponsor:  Novartis                                                     NCT#:   Faculty:  Mathias (PI), Oliver 5 year follow up of Ranibizamab vs laser for Retinopathy of Prematurity (ROP) Rainbow study 

AMD Ryan Initiative Study (ARIS)- Longitudinal Study of Early AMD and Reticular PseudodrusenSponsor:  National Eye Institute                                           COMIRB# 18-0520 Faculty:  Mandava (PI) The primary purpose of this study is to gather patient information for a large database to better understand and classify the changes that predict progression to vision loss in AMD.

Sponsor:  Regeneron Pharmaceuticals                               NCT#:  Faculty:  Oliver (PI), Mathias This study involves research and is conducted to determine the safety and effectiveness of a study drug called aflibercept and compare its effects with laser therapy.

Aurora-  A Prospective First in Human Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects with Autosomal Dominant Retinitis Pigmentosa (adRP) due to the P23H Mutation in the Rhodopsin Gene Sponsor:  ProQR Therapeutics                                                 NCT#:  Faculty:  Mathias (PI), Pecen, Mandava The purpose of this study is to find out if different dose levels (amounts) of the study drug are safe. This study will also measure whether the study drug improves vision.

Pavilion-  A Phase III, multicenter, randomized study of the efficacy, safety and pharmacokinetics of the port delivery system with ranibizumab in patients with diabetic retinopathy (PAVILION) Sponsor:  F. Hoffmann-La Roche                                            NCT#:  Faculty:  Oliver (PI), Pecen The purpose of this study is to evaluate the effects of ranibizumab when it is delivered by the Port Delivery System with ranibizumab (PDS) for non-proliferative Diabetic Retinopathy. 

GATHER2- A phase 3 multicenter, randomized, double-masked, sham controlled clinical trial to assess the safety and efficacy of intravitreal administration of ZIMURA™ (complement C5 inhibitor) in patients with geographic atrophy secondary to dry age-related macular degeneration Sponsor:  Iveric Bio                                                                       NCT#:  Faculty:  Pecen (PI), Mandava, Oliver, Olson, Mathias, Smith, Huvard, Chen The objectives of this study are to evaluate the effectiveness and safety of Zimura intravitreous administration compared to sham when administered in research participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

AU-011-202;  A Phase 2 trial of AU-011 via suprachoroidal administration with a dose escalation phase (open-label, ascending single and repeat dose) and a randomized, masked dose expansion phase designed to evaluate the safety and efficacy of AU-011 in subjects with primary indeterminate lesions and small choroidal melanoma Sponsor:  Aura Biosciences                                                        NCT#:  Faculty:  Oliver (PI), Mathias The purpose of this research study is to test the safety and efficacy of AU-011 at different doses and different number of doses of study drug when it is injected into the suprachoroidal space with one or two laser light applications and to find out what effects, if any, it has on research participants with a choroidal melanoma tumor or indeterminate lesion.

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Diabetic Macular Edema (RHINE)
Sponsor: Hoffmann-La Roche                                 NCT#: 
Faculty: Oliver (PI)

Radiation and Choroidal Melanoma
Sponsor: CUSOM/Department of Ophthalmology   NCT#: 
Faculty: Oliver (PI)
A prospective pilot study of surgical radiation shielding with vitrectomy and silicone oil tamponade, for the prevention of radiation-induced ocular injury in the treatment of choroidal melanoma with radioactive Iodine-125 plaque brachytherapy.

5-year follow-up of Ranibizamab vs laser for Retinopathy of Prematurity (ROP) 

Neuro-Ophthalmology: 

A Trial of Neuroprotection With ACTH in Acute Optic Neuritis (ACTHAR) Sponsors: UC Denver, UPenn, Mallinckrodt                   NCT#:  Faculty: Bennett, Shindler (Co-PIs)     Study Coordinator: Ruth Johnson 303-724-7885 Neuroprotection with ACTH for acute optic neuritis with onset of symptoms within 14 days of current episode.

Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Sponsor: Quark Pharmaceuticals                                 NCT#:   Faculty: Bennett (PI)                         Study Coordinator: Ruth Johnson 303-724-7885 Assess safety and tolerability of investigational product QPI-1007 via intravitreal injections and determine effect on visual functioning in subjects with recent onset (within 14 days) of NAION.

Contributions of Varicella Zoster Virus in Giant Cell Arteritis Sponsor:  UC Denver                                                COMIRB# 18-0244 Faculty:  Nagel (PI), Subramanian This study plans to learn more about varicella zoster virus (VZV) being a possible cause of giant cell arteritis (GCA). This study also aims to develop a fast and non-invasive diagnostic test for GCA.

Study to Assess the Efficacy and Safety of Raxone in LHON Patients (LEROS)
Sponsor: Santhera Pharmaceuticals                             NCT#: 
Faculty: Subramanian (PI), Bennett, Pelak
External Natural History Controlled, Open-Label Intervention Study to Assess the Efficacy and Safety of Long-Term Treatment With Raxone® in Leber's Hereditary Optic Neuropathy (LHON)

Gene Therapy for LHON 11778 (REFLECT)
Sponsor: GenSight Biologics                                       NCT#: 
Faculty: Subramanian (PI), Mandava, Mathias, Pecen, Palestine
The goal of this clinical trial is to assess the safety and efficacy of GS010, a gene therapy, in improving the retina functional & structural outcomes in subjects with LHON due to the G11778A ND4 mitochondrial mutation when vision loss duration is present up to one year.

Pediatric Ophthalmology:

Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)
Sponsor: University of Â鶹´«Ã½¸ßÇå, Denver                      NCT#: 
Faculty: Elias (PI), Braverman
Study Contact: 720-777-5401
Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation and antioxidant medication.

Cerebrotendinous Xanthomatosis (CTX) Prevalence Study
Sponsor: Retrophin Medical                                        NCT#: 
Faculty: McCourt (PI), Peoples
Study Contacts: 720-777-4470, 720-777-4708
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts.

SPOT Vision Screening
Sponsor: Children's Hospital Â鶹´«Ã½¸ßÇå, Welch Allyn       NCT#: 
Study Contact: Kyle Phillips, 720-777-0524
The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children.

Vision Rehabilitation:

IrisVision-  Usefulness and performance with the IrisVision headmounted video low vision aid in young individuals with congenital or early onset visual impairment
Sponsor:  Children’s Hospital Â鶹´«Ã½¸ßÇå, UC Denver            COMIRB# 19-2383
Faculty:  Engle (PI), Hanson, Lewerenz
The purpose of the study is to determine how useful the IrisVision low vision aid is to teenagers and young adults with congenital or early onset vision loss and how well subjects perform specific activities with the IrisVision. The IrisVision is a headset that is used by individuals with impaired vision to help them see better.